Welton Jeremy, Stratton Giles, Schoeninger Brittany, Low Min Hui, Moody Anita, D'Souza Wendyl
UCB Pharma, Level 1, 1155 Malvern Road, Malvern, VIC 3144, Australia; Department of Medicine - St Vincent's Hospital, The University of Melbourne, Clinical Sciences Building, Level 4 / 29 Regent Street, Fitzroy, VIC 3065, Australia.
IQVIA Australia, 8/201 Pacific Hwy, St Leonards, NSW 2065, Australia.
Epilepsy Behav. 2023 Apr;141:109145. doi: 10.1016/j.yebeh.2023.109145. Epub 2023 Mar 11.
To quantify sponsor-reported shortages of oral antiseizure medications in Australia, estimate the number of patients impacted, and the association between shortages and brand or formulation switching, and changes in adherence.
A retrospective cohort study of sponsor-reported shortages (defined as where the supply of a medicine will not or will not be likely to meet the demand over a 6-month period) of antiseizure medications reported to the Medicine Shortages Reports Database (Therapeutic Goods Administration, Australia); cross-referencing shortages to the IQVIA-NostraData Dispensing Data (LRx) database, a deidentified, population-level dataset collecting longitudinal dispensation data on individual patients from ∼75% of Australian community pharmacy scripts.
Ninety-seven sponsor-reported ASM shortages were identified between 2019 and 2020; of those, 90 (93%) were shortages of generic ASM brands. Of 1,247,787 patients dispensed ≥1 ASMs, 242,947 (19.5%) were impacted by shortages. Sponsor-reported shortages occurred more frequently before the COVID-19 pandemic versus during the pandemic, however, shortages were estimated to affect more patients during the pandemic than before the pandemic. An estimated 330,872 patient-level shortage events were observed, and 98.5% were associated with shortages of generic ASM brands. Shortages occurred at a rate of 41.06 shortages per 100 person-years in patients on generic ASM brands versus 0.83 shortages per 100 person-years in patients on originator ASM brands. In patients taking a formulation of levetiracetam affected by a shortage, 67.6% switched to a different levetiracetam brand or formulation during shortages compared with 46.6% in non-shortage periods.
Approximately 20% of patients on ASMs were estimated to have been impacted by an ASM shortage in Australia. The rate of patient-level shortages was approximately 50 times higher for patients on generic ASM brands versus originator brands. Shortages of levetiracetam were associated with formulation and brand switching. Improved supply chain management amongst sponsors of generic ASMs is needed to maintain the continuity of supply in Australia.
量化澳大利亚药品赞助商报告的口服抗癫痫药物短缺情况，估计受影响的患者数量，以及短缺与品牌或剂型转换之间的关联，以及依从性的变化。
对向药品短缺报告数据库（澳大利亚治疗用品管理局）报告的抗癫痫药物赞助商报告的短缺情况（定义为一种药物的供应在6个月内无法或不太可能满足需求）进行回顾性队列研究；将短缺情况与IQVIA-NostraData配药数据（LRx）数据库进行交叉比对，该数据库是一个经过去识别处理的人口水平数据集，收集了来自澳大利亚约75%社区药房处方中个体患者的纵向配药数据。
2019年至2020年期间，共识别出97起药品赞助商报告的抗癫痫药物短缺事件；其中，90起（93%）为通用型抗癫痫药物品牌短缺。在1,247,787名至少配药1种抗癫痫药物的患者中，242,947名（19.5%）受到短缺影响。药品赞助商报告的短缺事件在新冠疫情之前比疫情期间更频繁发生，然而，据估计疫情期间受短缺影响的患者比疫情之前更多。共观察到约330,872起患者层面的短缺事件，其中98.5%与通用型抗癫痫药物品牌短缺有关。通用型抗癫痫药物品牌的患者每100人年短缺发生率为41.06次，而原研抗癫痫药物品牌的患者每100人年短缺发生率为0.83次。在服用受短缺影响的左乙拉西坦剂型的患者中，67.6%在短缺期间换用了不同的左乙拉西坦品牌或剂型，而非短缺期间这一比例为46.6%。
据估计，澳大利亚约20%的抗癫痫药物患者受到抗癫痫药物短缺的影响。通用型抗癫痫药物品牌的患者层面短缺发生率约为原研品牌患者的50倍。左乙拉西坦短缺与剂型和品牌转换有关。需要改善通用型抗癫痫药物赞助商的供应链管理，以维持澳大利亚的药品供应连续性。
